NCT02434822

A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in Dominican Republic

Safety and Immunogenicity of Two Doses of Oral Cholera Vaccine (ShancholTM) in Subjects Aged 1 Year and Older in Dominican Republic

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 336 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

The aim of the study is to generate safety and immunogenicity data with Shanchol in The Philippines Objectives: * To describe the safety after each dose of Shanchol vaccine. * To describe the immunogenicity after each dose of Shanchol vaccine.

Detailed description

Healthy study participants aged 1 year and older will receive two doses of vaccine 14 days apart, and will be assessed baseline immunogenicity (pre-vaccination) and 14 days after each vaccine dose. Safety data will be collected for 14 days after the first dose and 30 days after the second dose.

Conditions

• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell	1.5 mL, Oral administration
BIOLOGICAL	Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell	1.5 mL, Oral administration
BIOLOGICAL	Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell	1.5 mL, Oral administration

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2016-07-01
• First posted: 2015-05-05
• Last updated: 2018-03-26

Locations

1 site across 1 country: Dominican Republic